Applying for a COVID-19 Emergency Use Authorization (EUA) Letter from FDA is no small feat, even though FDA has tried to simplify the process to expedite the availability of diagnostic products, personal protective equipment (PPE), and therapeutics to handle the SARS-CoV-2 pandemic. (You can find FDA’s guidance here.) The upside is a less rigorous regulatory pathway and the ability to market your product prior to receiving full marketing approval. The downside is that the process itself is unfamiliar to most and has been modified more than once since initiation. Furthermore, there are a number of pitfalls or submission package deficiencies that can cause delays and/or rejection of the application.
Common pitfalls include inadequate testing procedures, failure to provide study protocols, presenting topline data only, and incomplete manufacturing data. Fortunately, many of these can be avoided by developing a complete submission package from the onset, rather than engaging in back and forth with FDA regarding deficiencies, which can be time-consuming and delay time to market. For instance, when submitting an EUA package for a serological diagnostic, FDA requires a minimum number of positive and negative samples tested for every matrix (i.e., whole blood, serum, plasma) that the product is intended for. Many applicants only test whole blood but request authorization to market and label the test for all matrices.
The EUA regulatory pathway is not intended as a permanent solution, but rather as a temporary process to address a critical need. Once the EUA process for a particular category expires, all EUAs will become defunct and EUA products removed from the market unless applications have been submitted via the standard (i.e., long and laborious) regulatory pathways. Let ISS assist you in taking advantage of the EUA process now.
ISS has assisted with the submission of dozens of EUA packages, and not just for coronavirus-specific drugs, diagnostics, and devices. We’ve worked directly with FDA on behalf of our clients (as authorized US agents) in order to address deficiencies or revise submissions based on evolving requirements. We know this process inside and out.
Complete the form below to download our free white paper “Applying for an FDA Coronavirus EUA Letter” or contact us today to discuss how we can help.
Download our free white paper “Applying for an FDA Coronavirus EUA Letter”
We have summarized our extensive experience into this easy-to-read, practical guide.